The HOYA Group:
Founded in 1941 in Tokyo, Japan, HOYA Corporation is a global technology and med-tech company and a leading supplier of innovative high-tech and medical products.
HOYA's divisions and business units research and develop products utilized in the healthcare and information technology fields.
In the healthcare field, we provide medical device products such as eyeglasses, medical endoscopes, contact and intraocular lenses, orthopaedic implants, surgical/therapeutic devices and medical device reprocessing and disinfection solutions.
In the information technology field, we provide products such as optical lenses, photomasks, and blanks used in the manufacturing process for semiconductor and LCD/OLED devices, text-to-speech, human resources, and other software solutions and critical components for the mass memory and cloud storage industries.
With over 150 offices and subsidiaries worldwide, HOYA currently employs a multinational workforce of 37,000 people.HOYA Vision Care:
As a global leader in optical technology, HOYA Vision Care provides innovative vision care solutions for every stage of a patient's life.
A steadfast partner to Eye Care Professionals around the world, it stands at the forefront of optical excellence.With a global presence consisting of 43 laboratories and a growing team of 20,000 employees, HOYA Vision Care delivers innovative lenses and other vision care solutions to millions of people in 110 countries.
Every child deserves to have better treatment for their vision health.MiYOSMART is available in more than 30 countries worldwide and over 2 million parents across the world have already trusted the solution for their children.
We focus on a better tomorrow, today.HOYA Vision Care is a place where you can capitalise on your strengths and build a career that aligns with your aspirations.
It's a place where you can shape the way you work, guided by our CLEAR Values and empowered by generations of expertise.
You can help give the gift of sight to people worldwide.You can give back to the community by being involved in sustainability initiatives and choosing to become a One Vision ambassador.
You can be part of our amazing story.Company career website:
Careers | HOYA Vision Care
Follow us @
The Position
Strategies aligned with global/regional regulatory requirements and country businesses.
Monitor operational progression of pre-marketing authorization activities at cluster level through contact with cluster regulatory agencies or committees, as required.
Ensures all documents submitted to regulatory agencies are completed and well organized, in regulatory compliance, and presented in a manner that facilitates agency review.
The StakeholdersThe following are the key stakeholders for this position:
Internal:
APAC (TW/HK/ANZ/MY) Commercial, Research and Development, Clinical and Medical Affairs, Global Quality Assurance and Production Site Quality Assurances, Marketing, Global Key Accounts, Supply Chain Management, Legal & Compliance, Global/regional RA team, Human Resource, Finance
External:
Regulators and Trade Associations including TW FDA, HK MDD, AU TGA, MY MDA and distributors, regulatory consultants and Global Key Accounts
Major Responsibilities
Responsible for regulatory strategies plans, submission, and approval of marketing authorization applications for all new products and life cycle management of marketed products in cluster countries.
Responsible for maintaining records of regulatory submissions (in Agatha database system) and communications with the relevant regulatory agencies.Develop and maintain excellent working relationships with health authorities; identify regulatory risks for investigational and marketed products and develop strategies to minimize those risks.
Monitor and provide regulatory intelligence on new regulations, guidance and standards which impact medical devices in cluster countries.Key Deliverables (the main deliverables expected in the first 18-24 months)
Work, train and support partners inside Hoya, enabling them to create documentation that will support regulatory submissions and compliance.
Manage the review of regulatory submission documents for completeness and quality in accordance with cluster regulatory agency requirements and standards.
Provide functional and technical guidance with respect to submission of pre/post market applications and marketing applications.Manage and maintain regulatory related information including relevant logs, trackers and archives of regulatory submissions, correspondences, and into Agatha license database.
QualificationsEducation:
Bachelor's degreeor above, preferably in life science or medical engineering
Experience
Strong knowledge of regulatory requirements for TW QSD requirement and Class I, II medical devices in TW/HK/MY/ANZ (knowledge of ophthalmology products desirable)
Demonstrated flexibility while ensuring solidexecution and compliance.
Expertise in the development of strategic regulatory affairs plans
A track record of successful executionof regulatory submissions and ability to drive approvals for medical devices within targeted timelines
Proven ability to prepare training materials and deliver information to diverse audiences
Knowledge and hard/soft skills
High energy,collaborative mindset and experience initiating and leading organizational change
Strong communication, interpersonal, and consultative skills.
Ability to monitor and interpret external RA regulatory changes (e.g., EU MDR, TFDA regulation updates, UDI guidelines).
Demonstrated commitment to RA compliance.
Excellent command of English for written and verbal communication, with sensitivity to cultural diversity.
Behavioral attributes
Initiative, proactiveness, and independence
Willingness to embrace challenges
Strong business orientation
Mobility
Willingness to travel nationally and internationally for up to 20% of the time on average
Flexible Work Arrangements:
As this position involves a multi-regional scope, you will be required to participate in meetings and conference calls outside your regular work hours as required.
Show more Show less-
Tokyo BD ￥25,000,000 - ￥35,000,000 per year· BD 안세요 전속,Waters Corp.첟BD안세요 전속,Waters Corp. ...
-
Minato-ku BD Full time￥1,584,000 - ￥2,442,000 per year薬事担当シニアマネージャーは、ライフサイエンス部門の薬事機能を統括し、バイオサイエンス事業部と診断ソリューション事業部の両方を統括します。体外診断用医薬品(IVD)関連規制を含む国内外の規制へのコンプライアンスを確保するための薬事戦略の策定と実行을担当します。 · ...
-
Tokyo BD ￥100,000 - ￥200,000 per year+ · + · +h2+bJob summary/b/h2+pThe Senior Manager responsible for all aspects of regulatory affairs for BDB and DS./ppressible for all aspects of regulatory affairs for BDB and DS.+h2+bJob Description Summary/b/h2+pResponsible for all aspects of regulatory affairs +/pposition ove ...
-
Chiyoda Real当社は革新的な医療技術を通じて医療現場の課題解決に貢献するグローバルメドテック企業です。 · 本ポジションでは医療機器のISO13485に基づく品質マネジメントシステム(QMS)の運用および改善を担当いただきます。QMS文書を作成・改訂し続続的なプロセス改善を行うことができます。また手順書を作り規制対応を行い、および輸送管理安全管理(Vigilance)まで幅広い領域で仕事をすることができます。 · ...
-
Minato BD Nogales NorteBDは、ヘルスケア分野における多様なニーズに応える医療技術、デバイス、実験機器を開発する世界をリードする医療技術企業です。感染症の撲滅と治癒を目指す戦いにおいて最先端の研究を提供し国内外の人々に画期的な医療・バイオテクノロジーサービスへのアクセスを向上させるという私たちの使命で、私たちが求めています。 · ...
-
Tokyo Hoya Vision Care ￥800,000 - ￥1,200,000 per yearThe Cluster Senior Regulatory Affairs Manager will develop and maintain regulatory strategies for marketing authorization applications in cluster countries, ensuring compliance with global and regional requirements. The role involves monitoring operational progression of pre-mark ...
-
Tokyo Merck HealthcareThe Regulatory Affairs Senior Manager focuses on some of the following activities in Regulatory Affairs Group. This includes leading RA-related Health Authority interactions, preparing Japan NDA activities and HA's review for approval, and managing outsourcing vendors as needed. ...
-
Japan Ceva Sante AnimaleWe are committed to ensuring the highest possible level of care and well-being for farm animals (poultry, pigs, ruminants), companion animals (dogs and cats) and wildlife. Indeed, Our “Together, Beyond Animal Health” vision emphasizes that the health and wellbeing of people, anim ...
-
Tokyo IFFAre you passionate about advancing health and wellness through innovative bioscience solutions? · IFF is a global leader in flavors, fragrances, food ingredients and health & biosciences. · ...
-
Japan ColgateThe Regulatory Affairs Manager supports the Associate Director Regulatory Affairs EMEA/Japan to ensure compliance with regulations and statutes concerning development, manufacturing, distribution, marketing and sales of Hill's products in Japan. · ...
-
Tokyo Ryze Consulting Japan K.K. ￥8,000,000 - ￥12,000,000 per year大手外資系PR agencyのSenior Manager Public & Government Affairs · ...
-
Tokyo Regeneron Pharmaceuticals Full time￥9,000,000 - ￥12,300,000 per yearWe are now looking for in-country regulatory professionals to join our growing global regulatory team. · ...
-
Minato RegeneronWe are now looking for in-country regulatory professionals to join our growing global regulatory team.This is an exciting opportunity to demonstrate your knowledge in leading regulatory processes for biological products and regenerative medicines in Japan. · ...
-
Tokyo CooperVisionThe Regulatory Affairs Senior Specialist shall contribute and lead the Regulatory Affairs for the CooperVision Japan business. · ...
-
Tokyo Parexel Full time$100,000 - $200,000 per yearWhen our values align there's no limit to what we can achieve. · At Parexel we all share the same goal - to improve the world's health. From clinical trials to regulatory consulting and market access every clinical development solution we provide is underpinned by something speci ...
-
Tokyo, Tokyo Merck Healthcare ￥5,000,000 - ￥10,000,000 per yearThe Regulatory Affairs Senior Manager focuses on regulatory activities from development to life cycle management with global and Japan stakeholders. · Lead RA-related Health Authority (HA) interactions. · Lead New Drug Application (NDA) · ...
-
Tokyo IFF ￥60,000 - ￥120,000 per yearAre you passionate about advancing health and wellness through innovative bioscience solutions? · Channeling our passion for nature and bioscience into sustainable, life-enhancing technologies that power innovative solutions across healthcare, food, consumer and industrial market ...
-
Tokyo, Tokyo iNova Pharmaceuticals ￥4,500,000 - ￥8,000,000 per yearThe Company is seeking a Regulatory Affairs Manager to join its team on a full-time basis. The position is responsible for setting & executing the Japan regulatory strategy, managing product registration and maintenance, local regulatory support for the new product launch and loc ...
-
Tokyo, Tokyo GE HealthCare ￥6,000,000 - ￥12,000,000 per yearWe are seeking a highly motivated Regulatory Affairs Manager to lead regulatory strategies and ensure compliance for pharmaceutical and medical device products. This role plays a critical part in supporting product launches, ...
-
Greater Tokyo Area Kingfisher HR Solutions GroupThis position offers a unique opportunity for growth with an international cosmetics manufacturer expanding into Japan. · The role involves managing compliance systems for pharmaceuticals , quasi-drugs ,and cosmetics . · ...
-
Tokyo Ryze Consulting Japan K.K. ￥6,000,000 - ￥8,000,000 per year+" · ｦＧＡ７uff57 · + · ++Tokyo · ...
